I couldn't get back to the article, but my take on
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Posted On: 05/24/2017 8:31:46 PM
I couldn't get back to the article, but my take on it isn't that they're delaying anything that's ongoing. What I believe they were saying is that the next new trial the company will sponsor will be for MM.
If their strategy of selling the psoriasis cream as a cosmetic works, I frankly can't see any reason they must start a Phase 2 or 3 clinical trial that's being done with FDA concurrence. Such FDA trials often run into hundreds of millions of dollars because of the way the FDA insists on them being run.
I believe that psoriasis, acne, and a variety of other skin diseases don't require technical expertise to judge. I believe if some sort of feedback page were provided by the company for people who tried the cream for specific diseases the anecdotal evidence of efficacy could be great enough that over time insurance companies could be pushed to provide coverage without actual FDA approval.
Someone recently cited a court case where a court ordered an insurance company to pay for marijuana where the patient clearly had great benefit from it, and other approved medications were not as effective. Depending on the price of the cream, I believe that the insurance companies may find that treatment with the psoriasis cream may be far cheaper, and more effective than existing prescription psoriasis medications, and have far fewer negative side effects.
Personally I experienced an interesting skin condition after having a stem cell transplant. I had been warned to minimize sun exposure, and was finding my face very irritated after very limited exposure in spite of using lotions I'd previously used with very high SPF numbers. It turned out that it wasn't the sun causing the problem, but rather the new stem cells made me allergic to a brand of lotions I'd been using for years. I would suspect that OWCP's lotion may have a similar effect with some people. It may turn out that the lotion, not the cannabis component, could trigger allergies, but if so, hopefully it's in a very small percentage of those who try it. I don't know when we'll learn the results of the safety trial, but I wouldn't be surprised if a small fraction of those trying the cream are allergic to it.
Gary
If their strategy of selling the psoriasis cream as a cosmetic works, I frankly can't see any reason they must start a Phase 2 or 3 clinical trial that's being done with FDA concurrence. Such FDA trials often run into hundreds of millions of dollars because of the way the FDA insists on them being run.
I believe that psoriasis, acne, and a variety of other skin diseases don't require technical expertise to judge. I believe if some sort of feedback page were provided by the company for people who tried the cream for specific diseases the anecdotal evidence of efficacy could be great enough that over time insurance companies could be pushed to provide coverage without actual FDA approval.
Someone recently cited a court case where a court ordered an insurance company to pay for marijuana where the patient clearly had great benefit from it, and other approved medications were not as effective. Depending on the price of the cream, I believe that the insurance companies may find that treatment with the psoriasis cream may be far cheaper, and more effective than existing prescription psoriasis medications, and have far fewer negative side effects.
Personally I experienced an interesting skin condition after having a stem cell transplant. I had been warned to minimize sun exposure, and was finding my face very irritated after very limited exposure in spite of using lotions I'd previously used with very high SPF numbers. It turned out that it wasn't the sun causing the problem, but rather the new stem cells made me allergic to a brand of lotions I'd been using for years. I would suspect that OWCP's lotion may have a similar effect with some people. It may turn out that the lotion, not the cannabis component, could trigger allergies, but if so, hopefully it's in a very small percentage of those who try it. I don't know when we'll learn the results of the safety trial, but I wouldn't be surprised if a small fraction of those trying the cream are allergic to it.
Gary
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